Late last month, Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") and Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") each filed Motions to Exclude Evidence in Interference No. 106,115. Now CVC has filed its Opposition to Broad's motion to exclude and Broad has filed its responsive Reply.
Broad's motion to exclude was specifically directed to testimony from Dr. Phillip Zamore regarding "how a person having ordinary skill in the art ("POSA") allegedly would have understood (1) the March 2011 Deltcheva et al. reference's disclosures regarding tracrRNA, (2) the RNAi, pre-mRNA, and DNA systems he alleges are relevant to Deltcheva et al.'s disclosures, and (3) Dr. Zhang's October 24, 2011 email regarding the role of tracrRNA in the CRISPR-Cas9 cutting complex." According to Broad, what Dr. Zamore's declaration did not attest to was "(1) whether a 2012 POSA would have had a reasonable expectation of success of using CRISPR-Cas9 in eukaryotic cells; (2) the state of the art after the Jinek 2012 paper; or (3) relevant prokaryotic-based systems, such as Group II introns," all of which were issues upon which CVC Priority Motion relied. But these issues were attested to not by Dr. Zamore in support of CVC's priority claims but by another witness, who did not opine on them. Thus, CVC's proffer of Dr. Zamore's testimony on these matters was an attempt, in Broad's view, to "untimely seek to obtain expert testimony on these topics via improper re-direct testimony by Dr. Zamore" (i.e., during Broad's cross-examination of CVC's witness). And Broad asserted that its cross-examination of Dr. Zamore was properly limited to "the actual opinions expressed in Dr. Zamore's declaration and his qualifications," and thus did not "open the door" to the testimony CVC elicited on redirect examination.
CVC opposes Broad's motion to exclude on the grounds that Dr. Zamore's testimony on redirect was within the scope of Broad's cross-examination and was proffered to "clarify facts that were not made sufficiently clear by either cross examination or direct examination" and that Broad's assertion of prejudice is unfounded. Moreover, CVC asserts that it is "'entirely appropriate' to admit testimony elicited on redirect even where that testimony extends beyond the scope of cross-examination," citing Taskett v. Dentlinger, 344 F.3d 1337, 1339 (Fed. Cir. 2003). And CVC resorts to 37 C.F.R. § 1.671(b) and Fed. R. Evid. 611(b) for the rule that redirect testimony in proceedings before the PTAB were permissible where such testimony "clarify[ies] facts that were not made sufficiently clear by . . . cross examination." Because Broad's motion does not address these standards nor assert a basis in view of them for CVC's purported transgression thereof, CVC's Opposition maintains that Broad fails to provide the Board with any basis for granting their motion. CVC further argues that Broad has failed to establish any prejudice to itself, because Broad has had a "full and fair opportunity to re-cross Dr. Zamore" under 37 C.F.R. § 42.53(c)(2), but "chose not to do so."
CVC's Opposition sets forth in detail, point by point under interference rules, its basis for contending that Broad did not establish a basis for the Board to grant their motion to exclude. CVC alleges that Broad has mischaracterized Dr. Zamore's redirect testimony, which was directed (in CVC's view) to a question that "has been discussed in nearly every filing throughout the course of this Interference": whether a person of skill in the art "would have understood the sgRNA CRISPR-Cas9 system to work in eukaryotes without needing any special instructions or conditions, based on the skilled artisan's experience with comparable prior art systems." CVC's brief sets forth the dynamics of the testimony elicited from this witness by Broad during its cross-examination and CVC's questions on redirect examination, supporting its assertion that the testimony Broad seeks to exclude is properly within the scope of Broad's cross-examination. CVC asserts accordingly that to the extent that Dr. Zamore's testimony was "expanded," the Board can consider it "provided such testimony provides the PTAB valuable clarity and context for his previous answers, many of which answered questions from Broad's counsel that were confusing or misleading in the absence of an understanding of the broader implications of the discussion," citing Taskett. These relationships between Broad's questioning on cross-examination and CVC's redirect are set forth in this table:
The Opposition brief further exemplifies CVC's argument specifically as relates to its inquiry on Dr. Zamore's redirect testimony regarding comparisons (elicited on Broad's cross-examination) between CRISPR-Cas9 and other RNA-based regimes ("[r]ibozymes, Group II introns, and riboswitches"). CVC contends these are not the most compatible prior art systems, as Dr. Zamore explained for the Board's benefit on re-direct (testifying that "ZFNs and TALENs are far more comparable than any of these RNA systems"). In view of the clarifying nature of this testimony, CVC argues that there no basis to exclude it under Taskett or other Federal Circuit precedent.
CVC further contends that there is no prejudice to Broad, because the topics that were the subject of Dr. Zamore's redirect testimony were "not news" and that "[n]othing in Dr. Zamore's redirect testimony raised any issues that Broad and its experts have not already briefed extensively," noting that Broad had proffered Dr. Breaker's expert witness testimony on these issues.
Finally, CVC argues that Broad had the opportunity under 37 C.F.R. § 42.53(c)(2) to recross Dr. Zamore but did not do so.
Broad's Reply repeats the arguments already made in Broad's Motion to Exclude, here calling CVC's Opposition arguments "a transparent attempt to circumvent the rule against submitting reply declarations without leave." Broad ties these efforts to the Board's earlier denial of CVC's request for leave to file reply declarations with regard to CVC Reply 2 (see "CVC Files Reply to Broad's Opposition to CVC's Priority Motion"). Broad's Reply discusses in detail the scope of Dr. Zamore's testimony on cross-examination and on re-direct, arguing that his cross-examination testimony was far less expansive than CVC contends. The Reply notes that Dr. Zamore's declaration was filed in support of CVC's Opposition to Broad's priority motion and that nothing in either the Opposition nor the declaration was directed to questions of whether the skilled worker would have had a reasonable expectation of success at operable CRISPR-Cas9 in eukaryotic cell nor comparisons to other prior art systems. Broad points out that these considerations apply to CVC's Priority Motion (fairly, because Broad itself has put these issues into question) and that CVC's expert asserted in support of CVC's priority motion did not address these issues.
Broad supports its argument that the Board should exclude this evidence as CVC overreach by noting that CVC has not cited anything (not "a single page") in Dr. Zamore's declaration that supports its argument that the Board should not exclude this testimony. Moreover, Broad argues that:
Dr. Zamore's declaration does not contain any discussion of the obstacles and difficulties presented when adapting a prokaryotic system, such as CRISPR-Cas9, for use in a eukaryotic cell, nor any discussion of prior art systems such as Group II Introns or ZFNs/TALENs—indeed, Dr. Zamore's declaration does not contain a single mention of those systems. These topics and systems have long been live issues here, and there is no excuse for CVC to have neglected addressing them in the declarations served with its Priority Motion.
Even if this were not the case, Broad argues that CVC cannot be permitted to "grossly expand the scope of his declaration via re-direct to systems not even mentioned in the declaration" (specifically Group II Introns and ZFNs/TALENs)(emphasis in Reply). Broad asserts that its cross-examination was limited to the opinions he expressed in his declaration and what CVC attempts to introduce in testimony Broad opposes because it goes beyond this testimony and unfairly prevents Broad from cross-examining Dr. Zamore on these issues (despite any culpability Broad may have for failing to re-cross Dr. Zamore during his deposition).
Broad also reiterates its argument in its Motion to Exclude that the testimony it asks the Board to exclude was "a clearly prepared Q&A with CVC's counsel on re-direct on all three systems," i.e., Group II Introns, ZFNs and TALENs. Broad set forth with specificity its challenges to the portions of Dr. Zamore's cross-examination testimony CVC cites in support of its arguments against the Board excluding this evidence, contending that these portions do not support the scope of the redirect testimony CVC attempts to include and nor does the authority CVC cites as favoring its position (including Taskett and Chrimar Holding Co., LLC v. ALE USA Inc., 732 F.App'x 876 (Fed. Cir. 2018)).
In response to CVC's assertion that Broad squandered its opportunity to re-cross examine Dr. Zamore on his redirect testimony Broad argues that:
[A]ll this does is highlight the unfairness and prejudice of CVC's canned re-direct. There was no surprise to CVC that it needed to address [reasonable expectation of success] and prior art systems with a declaration in support of its opening Priority Motion. CVC decided not to do so, and then ambushed Broad by eliciting it on Dr. Zamore's re-direct. Broad did not have an opportunity to submit a rebuttal declaration and evidence or prepare a considered cross-examination of a properly disclosed opinion from Dr. Zamore. To contend Broad should have cross-examined Dr. Zamore on his undisclosed and improperly elicited "re-direct" confirms that prejudicing Broad was CVC's goal—not merely a byproduct of its improper re-direct.
The Board will decide whether to exclude this or any other testimony included in the Parties' Motions prior to Oral Hearing, for which the Board has not set a date.